UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050017 |
|---|---|
| Receipt number | R000056979 |
| Scientific Title | Impact of developmental and cognitive traits on the efficacy of cognitive training for healthy adults |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2023/01/26 14:09:38 |
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Basic information
Public title
A research on the efficacy of cognitive training for healthy adults
Acronym
A research on the efficacy of cognitive training for healthy adults
Scientific Title
Impact of developmental and cognitive traits on the efficacy of cognitive training for healthy adults
Scientific Title:Acronym
Impact of developmental and cognitive traits on the efficacy of cognitive training for healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a cognitive training program targeting social cognition or reading/writing and to examine its efficacy on cognitive and social functions in healthy adults. In addition, the applicability of the program to ASD is examined to determine whether developmental and cognitive traits associated with ASD affect the efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Launguage and social cognitive functions: emotion recognition tasks, reading/writing tasks
Key secondary outcomes
Neurocognitive functions: MCCB, VC subtests of WAIS-III
Social functioning: RSE, GSE, IRI, LSAS, SFS, WHOQOL26
Developmental and cognitive traits: AQ, TAS-20, SPQ
MRI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Social cognitive training (SCST): 2 hours once a week, 6 sessions
Interventions/Control_2
Social cognitive training (CR): 2 hours once a week, 6 sessions
Interventions/Control_3
Social cognitive training (SCST+CR): 2 hours once a week, 6 sessions
Interventions/Control_4
Reading/writing training (writing): 2 hours once a week, 6 sessions
Interventions/Control_5
Reading/writing training (reading): 2 hours once a week, 6 sessions
Interventions/Control_6
Reading/writing training (reading and writing): 2 hours once a week, 6 sessions
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults who can participate in cognitive traing conducted online
Key exclusion criteria
Individuals with a history of or a current mental disorder, substance or alcohol abuse, traumatic head injury, cerebrovascular disorder, neurodegenerative disease, intellectual disability, any other medical condition significantly affecting brain function ,or during pregnancy or postpartum period
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Murai |
Organization
Kyoto University
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4947
scst.kyoto@gmail.com
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Otsuka |
Organization
Kyoto University
Division name
Department of Psychiatry
Zip code
606-8507
Address
54 shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4947
Homepage URL
scst.kyoto@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 12 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056979
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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